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Med Shop Total Care, Inc. - 581309 - 10/11/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/med-shop-total-care-inc-581309-10112023 … Dear Ms. … of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case …
Boehringer Ingelheim Animal Health USA - 674535 - 03/01/2024
… Senvelgo (velagliflozin oral solution) CMS #: 674535 WARNING LETTER Dear Mr. Legg: The U.S. Food and Drug … misleading promotional communication contradicts the boxed warning, contraindications, and approved indication of your … insulin.” 2 Senvelgo’s FDA-approved PI contains a boxed warning due to increased risk of diabetic ketoacidosis (DKA) …
Creative Science, Inc. - 554119 - 05/23/2018
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/creative-science-inc-554119-05232018 … … (313) 393-8100 Fax: (313) 393-8139 May 23, 2018 WARNING LETTER Case# 554119 UPS NEXT DAY SIGNATURE …
Savvy Holistic Health dba Holistic Healthy Pet - 605915 - 04/07/2020
… … WARNING LETTER Date: April 7, 2020 … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Med-Pharmex, Inc. - 522676 - 05/17/2017
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/med-pharmex-inc-522676-05172017 … U.S. Food … District 19701 Fairchild Road Los Angeles, CA 92612 WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED …
Allure Imports - 613211 - 04/07/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/allure-imports-613211-04072021 … WARNING LETTER Date: April 7, 2021 RE: Unapproved and …
ADM Animal Nutrition - 657846 - 10/23/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/adm-animal-nutrition-657846-10232023 … WARNING LETTER CMS Case #657846 October 23, 2023 Dear Mr. …
Montana Emu Ranch Company Inc - 509205 - 04/20/2017
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/montana-emu-ranch-company-inc-509205-04202017 … … MAIL RETURN RECEIPT REQUESTED In reply refer to Warning Letter SEA 17-11 Penelope S. Collins, Owner Montana …
Bea Lydecker’s Naturals, Inc. - 616439 - 02/09/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/bea-lydeckers-naturals-inc-616439-02092022 … February 9, 2022 In reply, refer to CMS 616439 WARNING LETTER Dear Ms. Lydecker-Hayford: The U.S. Food and …
Kingdom Harvest - 625058 - 05/04/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/kingdom-harvest-625058-05042022 … WARNING LETTER May 4, 2022 RE: # 625058 Dear Ms. Rogers: This …